MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES— 510(k) K113810

Name: FDA 510(k) clearance K113810
Creator: U.S. Food and Drug Administration
Published: 2012-03-08

Substantially Equivalent

Alma Lasers, Inc.

FDA 510(k) clearance K113810 for MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES, Substantially Equivalent on 2012-03-08. Applicant: Alma Lasers, Inc.. Device class: 2.

Clearance details

Applicant: Alma Lasers, Inc.
Product code: Code PDZ
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2011-12-23
Decision date: 2012-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo Grove, IL, US

Download summary PDF View on FDA.gov ↗

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